This 2-year renewal project builds on our previous NHGRI-funded project on "Managing Incidental Findings in Human Subjects Research" (#1 R01 HG003178-01A1). Using that project's outcomes as a foundation, we now propose a 2-year renewal project to address one of the most pressing issues facing genomic research: What information, if any, about incidental findings (IFs) and individual research results (IRRs) should be offered back to the individuals whose DNA and data are collected and housed in genomic biobanks and archived datasets? We will convene a multidisciplinary Working Group in order to develop normative consensus recommendations on managing IFs and IRRs in genomic research using biobanks and large archives. There are 10 components to this project: (1) identification of U.S. biobanks (defined in this project to include datasets and DNA samples archived for reanalysis) and websites where available;(2) collection of the relevant literature, guidelines, law, and regulations, including international guidelines and statements on biobank management;(3) collection and content analysis of biobank websites (including policy statements, consent forms, FAQs answers, and other informative material) to analyze approaches to IFs and return of IRRs;(4) collection and content analysis of relevant documents by emailing the manager or director of biobanks identified, including those with no or uninformative websites;(5) collection and content analysis of relevant non-U.S. documents from the websites of major international (non-U.S.) biobanks with websites in English and by email to the manager or director of each biobank;(6) development of normative consensus recommendations providing guidance on how to handle IFs and return of IRRs in genomic biobank research and soliciting feedback;(7) authorship of targeted analyses of this problem and the legal aspects;(8) presentation of consensus recommendations and targeted analyses at a public conference for feedback;(9) publication as a symposium in a prominent journal;and (10) development of a publicly available website containing tools for biobanks, their ethics oversight bodies, IRBs, researchers, research participants, scholars, and others on managing IFs and return of IRRs, including an annotated bibliography with web links. To accomplish this, the project will involve 3 methodologies: (A) a normative process to reach consensus on how IFs and IRRs should be managed in genomic research involving biobanks and archived samples and data, supported by (B) empirical and analytic research systematically collecting the relevant literature, guidance documents, regulations, and law, with structured content analysis of (a) the policy, informational, and consent documents publicly available on biobank websites, and (b) additional documents collected by email query from biobank managers and directors, and (C) international comparison of the policies on return of IFs and IRRs among major DNA biobanks with English-speaking websites. PUBLIC HEALTH RELEVANCE: In order to understand the genetic contribution to a host of diseases and conditions of great importance to public health, scientists are increasingly assembling large biobanks archiving many individuals'DNA and health information for scientific reanalysis over time. However, there is no clarity about what individual health information, if any, should be given back to those people generous enough to donate;some prominent biobanks are giving back none at all. This project will convene leading experts on bioethics, genomics, biobanking, and law to recommend ethical policies and practices on return of both incidental findings and individual research results that may have importance for the donor.